Status:
RECRUITING
A PROspective Faecal MIcrobiota tranSplantation Trial to Improve outcomEs in Patients With Cirrhosis
Lead Sponsor:
King's College London
Collaborating Sponsors:
Guy's and St Thomas' NHS Foundation Trust
Imperial College London
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A feasibility trial called PROFIT has previously shown that FMT administered endoscopically into the jejunum in patients with cirrhosis is safe and feasible and have identified some potential mechanis...
Detailed Description
There is an evolving crisis of chronic liver disease (CLD) in the UK and it is the only major chronic disease which is on the rise. The advanced stages of CLD, known as cirrhosis (a hardening and scar...
Eligibility Criteria
Inclusion
- Aged ≥ 18 years
- Confirmed Alcohol-related (ALD) or Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) or MetALD cirrhosis based on clinical, radiological and/or histological criteria.
- MELD score 8-16
- Patients with alcohol-related cirrhosis who must have an active alcohol consumption on average ≤20 grams/day \[1 unit of alcohol contains 10mLs or 8g of alcohol\].
- Patients must be deemed to have the capacity to provide written informed consent to participate.
Exclusion
- Moderate, severe or life-threatening food allergy (e.g., peanut allergy)
- Pregnancy or planned pregnancy\*. Urine testing will be performed at screening to rule out pregnancy in females.
- Breast-feeding
- Patients treated for acute variceal bleeding, infection, overt hepatic encephalopathy, bacterial peritonitis or ACLF within 14 days prior to randomisation.
- Active alcohol consumption of \>20 grams/day \[1 unit of alcohol contains 10mLs or 8g of alcohol\]
- Had a previous liver transplant
- Patients with inflammatory bowel disease.
- Patients with coeliac disease.
- Patients with a history of prior gastrointestinal resection or surgery that could change the gut microbiome or result in bacterial overgrowth e.g. gastric bypass
- Active malignancy including hepatocellular carcinoma
- Patients with an expected life expectancy \<6 months or listed for liver transplantation
- Infected with HIV, hepatitis B or C \[patients who have undetectable hepatitis B or C DNA/RNA can be recruited\].
- Patients who have received antibiotics or probiotics (excluding food stuffs containing 'live bacteria' such as live yoghurts, kefir, fermented vegetables such as sauerkraut/kombucha or cheese) within 7 days prior to randomisation.
- Swallowing disorder, oral-motor dyscoordination or likely inability/unwillingness to ingest study medication.
- Patients who have received another investigational drug or device within 4 months prior to randomisation.
- Patients, who in the opinion of the PI, have a medical condition, or other relevant psychological, familial, or social factor that may jeopardise their health, compliance, or influence the trial integrity in any way.
Key Trial Info
Start Date :
June 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06461208
Start Date
June 21 2023
End Date
June 30 2028
Last Update
February 24 2026
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Basildon University Hospital
Basildon, United Kingdom, SS16 5NL
2
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
3
Southmead Hospital
Bristol, United Kingdom, BS10 5NB
4
Bristol Royal Infirmary
Bristol, United Kingdom, BS2 8HW